Multi-chambered containers

ABSTRACT

Multi-chambered containers having individually arranged chambers and methods of using same are provided. In a general embodiment, the present disclosure provides a multi-chambered container including a first chamber, a second chamber, and a third chamber. A first peelable seal separates the first and third chambers. The first peelable seal is independently openable by selective application of external pressure to the first chamber. A second peelable seal separates the second and third chambers. The second peelable seal is independently openable by selective application of external pressure to the second chamber. The first chamber is separated from the second chamber by a permanent seal defining a transverse opening.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/017,094 filed on Dec. 27, 2007, the entiredisclosure of which is hereby incorporated by reference.

BACKGROUND

The present disclosure is directed to packaging products. Morespecifically, the present disclosure is directed to multi-chamberedcontainers for the selective admixture of solutions.

Containers having sub-chambers are widely used to separately store twoor more components. The components can be mixed inside the container andadministered to a patient through a tube attached to the container. Thecomponents can be in a powder or liquid form and are typically mixedtogether to form a therapeutic solution. Such solutions can includeintravenous solutions, nutritional solutions, drug solutions, enteralsolutions, parenteral solutions, dialysis solutions, pharmacologicalagents including gene therapy and chemotherapy agents, and many otherliquids that may be administered to a patient.

The storage chambers of the multi-chambered containers are oftenseparated by a frangible heat seal. Peelable seals are among thefrangible seals used that permit the seal to be separated by pulling onopposite sides of the container to mix the contents of the separatedchambers. Nevertheless, multi-chambered containers are currentlydesigned so that once the peel seal between chambers is broken, theentire contents from each chamber mixes together. As a result, thesemulti-chambered containers provide little control over the selectivemixture of components in the storage chambers.

SUMMARY

The present disclosure is directed to multi-chambered containers thatcan be used for the selective admixture of components within thechambers. In a general embodiment, the present disclosure provides amulti-chambered container including a first chamber, a second chamber,and a third chamber. A first peelable seal separates the first and thirdchambers and is independently openable by selective application ofexternal pressure to the first chamber. A second peelable seal separatesthe second and third chambers and is independently openable by selectiveapplication of external pressure to the second chamber. The firstchamber is separated from the second chamber by a permanent sealdefining a transverse opening. At least one of the first chamber andsecond chamber is dimensioned to facilitate one-handed gripping of thechamber to apply the external pressure. For example, the transverseopening can be dimensioned to admit a human hand to apply the externalpressure.

In an embodiment, the third chamber can contain a parenterallyadministrable base solution. In another embodiment, the third chambercan be empty and sized to contain the entire contents of the firstchamber and the second chamber.

In an embodiment, the container is made from a film including one morematerials such as, for example, polyolefins, polyamides, polyesters,polybutadiene, styrene and hydrocarbon copolymers, polyimides,polyester-polyethers, polyamide-polyethers, or a combination thereof.More specifically, the film can include one or more materials such as,for example, polyethylene homopolymers, ethylene α-olefin copolymers,polyethylene copolymers, polypropylene homopolymers, polypropylenecopolymers, styrene and hydrocarbon random copolymers, styrene andhydrocarbon block copolymers, or a combination thereof.

In an embodiment, the first peelable seal and the second peelable sealare activated by a force ranging from about 3 N/15 mm to about 30 N/15mm. In addition, the first peelable seal can have a first activatingforce and-the second peelable seal can have a second activating force.The second peelable seal activating force can be greater than the firstpeelable seal activating force. The difference between the firstpeelable seal activating force and the second peelable seal activatingforce can be greater than about 1 N/15 mm and less than about 5 N/15 mm.

In an embodiment, at least a portion of the first peelable seal and thesecond peelable seal has a shape such as semicircular, rectangular,trapezoidal, polygonal, or a combination thereof.

In an embodiment, the first chamber and the second chamber containcomponents of a peritoneal dialysis solution. Alternatively, the firstchamber and the second chamber can contain components of a parenteralnutrition solution.

In an embodiment, the multi-chambered container further includes a fluidoutlet port in fluid communication with the third chamber. A peelablesafety seal can separate the outlet port from the third chamber. Thesafety seal can have a seal strength selected to impede opening of thesafety seal unless at least one of the first and second peelable sealshave first been opened. The multi-chambered container can furtherinclude a tube in fluid communication with at least; one of the firstchamber and the second chamber.

In another embodiment, the present disclosure provides a multi-chamberedcontainer including at least two plies of a flexible polymer filmdefining a first chamber, a second chamber, and a third chamber formedbetween the plies. A first peelable seal separates the first and thirdchambers and is independently openable by selective application ofexternal pressure to the first chamber. A second peelable seal separatesthe second and third chambers and is independently openable by selectiveapplication of external pressure to the third chamber. The first andthird chambers are separated by a permanent seal defining a transverseopening through the plies.

In an alternative embodiment, the present disclosure provides amulti-chambered container including at least two plies of a flexiblepolymer film defining a first chamber, a second chamber, a thirdchamber, and a fourth chamber formed between the plies. A first peelableseal separates the first and fourth chambers and is independentlyopenable by selective application of external pressure to the firstchamber. A second peelable seal separates the second and fourth chambersand is independently openable by selective application of externalpressure to the second chamber. A third peelable seal separates thethird and fourth chambers and is independently openable by selectiveapplication of external pressure to the third chamber. The first chamberis separated from the second chamber and the second chamber is separatedfrom the third chamber by a permanent seal defining a transverse openingthrough the plies. At least one of the first chamber, second chamber,and the third chamber is dimensioned to facilitate one-handed grippingof the chamber to apply the external pressure. For example, thetransverse opening can be dimensioned to admit a human hand to apply theexternal pressure.

In an embodiment, the fourth chamber is sized to facilitate mixing ofthe contents of any combination of the first, second, and thirdchambers. The multi-chambered container can further include a fluidoutlet port in fluid communication with the fourth chamber. A peelablesafety seal can separate the outlet port from the fourth chamber. Thesafety seal can have a seal strength selected to impede opening of thesafety seal unless at least one of the first, second, and third peelableseals have first been opened. The container can also include one or moretubes in fluid communication with at least one of the first chamber, thesecond chamber, and the third chamber.

In yet another embodiment, the present disclosure provides a method ofadministering a product. The method comprises providing a containerincluding a first chamber having a first component, a second chamberhaving a second component, and a third chamber. The container isconstructed and arranged according to embodiments of the presentdisclosure. The method further comprises compressing at least one of thefirst chamber and the second chamber to allow the component from thecorresponding compressed chamber to flow through into the third chamber.The squeezing can be performed by a user's hand squeezing the specificchamber.

The method can further comprise compressing the remaining chamber toallow the component from the remaining compressed chamber to flowthrough into the third chamber to form a mixed component. The componentsfrom the first and second chambers can be mixed in the third chamber andadministered through a fluid outlet port in fluid communication with thethird chamber to a patient.

An advantage of the present disclosure is to provide an improvedmulti-chambered container have the capability for selectivelyadministering the individual contents from specific chambers of thecontainer.

Another advantage of the present disclosure is to provide an improvedmulti-chambered container that allows the reconstitution of customtailored solutions.

Yet another advantage of the present disclosure is to provide a methodof custom administering components of a multi-chambered container.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a front view of the multi-chambered containerincluding two chambers that lead into a mixing chamber in an embodimentof the present disclosure.

FIG. 2 illustrates a front view of the multi-chambered containerincluding three chambers that lead into a mixing chamber in anotherembodiment of the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates to multi-chambered containers havingindividually arranged storage chambers. In alternative embodiments, themulti-chambered containers allow an operator/user to selectively mix aspecific amount of one or more components (e.g. solutions/concentrates)from each storage chamber into a holding/mixing chamber situated belowthe storage chambers containing the components. The holding/mixingchamber could be either empty at start of the mixing or be filled with abase solution that could potentially be infused as is (alone) to apatient. The mixing of the components contained in the storage chamberscan be performed by sequentially applying a specific amount of pressureon each of the individual storage chambers containing the specificcomponents.

In a general embodiment shown in FIG. 1, the present disclosure providesa container 10 including a body 12 defined by a film. The container 10includes a first chamber 30, a second chamber 40, and a third chamber50. The container 10 may be made, for example, from two plies of thefilm that are sealed about the periphery of the container 10 at edges14, 16, 18, and 20 to form outer permanent (cohesive) seals. In theillustrated embodiment, two plies of film (one for each side) are usedalthough additional plies of film can be used. The size and dimensionsof the container 10 and chambers 30, 40, and 50 can vary depending onthe application.

A first peelable (adhesive) seal 32 separates the first chamber 30 andthe third chamber 50. The first peelable seal 32 is independentlyopenable by selective application of external pressure to the firstchamber 30. A second peelable seal 42 separates the second chamber 40and the third chamber 50. The second peelable seal 42 is independentlyopenable by selective application of external pressure to the secondchamber 40. Accordingly, the component stored in the first chamber 30can be added to chamber 50 separately from the component stored in thesecond chamber 40 and vice versa. Moreover, the amount of pressureseparately applied to the first and second chambers 30 and 40 cancontrol how much component is removed from the chambers.

The first chamber 30 is separated from the second chamber 40 by apermanent seal 52 defining a transverse opening 54. As a result, thefirst chamber 30 and/or the second chamber 40 can be dimensioned tofacilitate one-handed gripping of the chambers 30 and 40 to apply theexternal pressure. For example, the transverse opening 54 positionedbetween the individual chambers 30 and 40 allows for a pressure to beapplied on any one of the individual chambers 30 or 40 without exertingpressure on the other chambers.

By pressurizing, one at a time, a specific chamber (30 or 40) containingone or more components to be mixed together to satisfy the specificneeds of a given patient, a user or care giver can prepare a mixedformulation having specified or selective amounts from the individuallystored components of chambers 30 and 40. The chambers 30 and 40 can bemarked with unit markings (e.g. showing volume remaining) to inform theuser how much of the component has been removed from that chamber. Theselective amount of the stored components can be thoroughly mixed in thethird chamber 50 prior to being infused or administered to the patient.

The first peelable seal 32 and the second peelable seal 42 can beconstructed and arranged to allow a precise amount of component to passthrough between chambers. For example, a specified portion of thepeelable seals 32 and 42 can open that corresponds to the amount ofpressure or force applied to the chambers 30 and 40, respectively. Inaddition, the first peelable seal 32 and the second peelable seal 42 canbe in the form of re-peelable/re-sealable seals that can be closed aftera specified amount of component has been squeezed from their respectivechambers into the third chamber 50.

In an embodiment, the transverse opening 54 has a width (side to side)greater than 5 mm. The transverse opening 54 can also have a largerwidth such as, for example, a width greater than 6 mm, greater than 7mm, greater than 8 mm, greater than 9 mm, greater than 10 mm, and thelike. In another embodiment, the transverse opening 54 has a length (topto bottom) greater than 5 cm. The transverse opening 54 can also have alarger length such as, for example, a width greater than 6 cm, greaterthan 7 cm, greater than 8 cm, greater than 9 cm, greater than 10 cm,greater than 11 cm, greater than 12 cm, greater than 13 cm, greater than14 cm, greater than 15 cm, greater than 16 cm, greater than 17 cm,greater than 18 cm, greater than 19 cm, greater than 20 cm, and thelike. For example, the transverse opening 54 can be dimensioned to admita human hand 70 (e.g. adult/care giver) to apply the external pressure.

The first chamber 30 and the second chamber 40 can be storage chambersfor holding one or more components such as a solution or concentrate.The third chamber 50 can be a holding/mixing chamber. For example, thecomponents or solutions stored in chambers 30 and 40 can provide areconstituted therapeutic solution when mixed together in chamber 50prior to usage. Alternatively, the third chamber 50 can be pre-filledwith a base solution that could be infused alone or in combination withone or more of the solutions/concentrates contained in the first chamber30 and/or the second chamber 40, which can be selectively put in fluidcommunication with the third chamber 50. Such solutions can includeintravenous solutions, nutritional solutions, drug solutions, enteralsolutions, parenteral solutions, dialysis solutions, and many otherliquids that may be administered to a patient.

In an embodiment, the first peelable seal 32 and the second peelableseal 42 can be activated by a force ranging from about 3 N/15 mm toabout 30 N/15 mm. The force can be applied, for example, from a usersqueezing sides of the container 10 so that the components stored withinchambers 30 or 40 press against the first peelable seal 32 and thesecond peelable seal 42, respectively.

In another embodiment, the first peelable seal 32 has a first activatingforce (e.g. amount of force necessary to open the seal) and the secondpeelable seal 42 has a second activating force. The second peelable sealactivating force is greater than the first peelable seal activatingforce. The difference between the first peelable seal activating forceand the second peelable seal activating force can be greater than about1 N/15 mm and less than about 5 N/15 mm.

The peelable seals 32 and 42 can have any suitable shape. For example,as illustrated in FIG. 1, the peelable seals 32 and 42 can be in theform of semi-circular seals having an apex that is oriented towards theinside of the individual chambers 30 and 40, respectively. In anembodiment, at least a portion of the peelable seals 32 and 42 has ashape such as semicircular, rectangular, trapezoidal, polygonal, orcombinations thereof. The peelable seals 32 and 42 can also be serratedto facilitate their opening upon application of a pressure on thecorresponding chamber.

As illustrated in FIG. 1, the container 10 can further include anadministration tube 60 and a medication tube 67 in fluid communicationwith the third chamber 50. Medication tube 67 provides communicationwith the interior of chamber 50 and is equipped with a seal such asseptum 69 that allows components such as a liquid to be added to orremoved from the multi-chambered container, for example, after thecontents of chambers 30 and 40 have been mixed. The tube 60 can alsoinclude a membrane (not shown) that seals shut the tube 60 and can bepierced by, for example, a cannula or spike of an administration set.The tube 60 can be sealed until the time to access the contents of thecontainer 10.

A peelable safety seal 62 can surround an opening of the tube 60. Thesafety seal 62 can have a seal strength selected to impede opening ofthe safety seal 62 unless at least one of the first and second peelableseals 32 and 42 have first been opened. The peelable safety seal 62 canhave any suitable shape.

In an embodiment, the container 10 can further include one or more tubes64 in fluid communication with the first chamber 30 and/or the secondchamber 40. The tubes 64 can provide communication with the interior ofchambers 30 and 40 and allow components such as solutions/concentratesto be added to or removed from chambers 30 and 40. For example, thetubes 64 can be used as fill ports for chambers 30 and 40 or as additiveports to allow addition of a medication or other additive to one of thechambers after the chamber has been filled and sealed. The tubes 64 canbe capped or sealed after the chambers 30 and 40 have been filled withthe desired components. The number, size, and dimensions of the fillingtubes 64, medication tube 67, and administration tube 60 can varydepending on the application.

The container 10 and the peelable seals 32 and 42 can be constructedfrom films able to make peal seal layers in accordance with embodimentsof the present disclosure. The peelable seal layer films can allow bothpeelable and permanent seals to be created. Thus, the permanent sideseals 14, 16, 18, and 20 as well as the peelable seals 32, 42, and 52can be created from the same layer of film.

In the illustrated embodiment, any portion of the container 10 can bemade from one or more suitable polymer materials. Suitable polymermaterials include polyethylene homopolymers, ethylene α-olefincopolymers, polyethylene copolymers, polypropylene homopolymers,polypropylene copolymers, styrene and hydrocarbon random copolymers,styrene and hydrocarbon block copolymers, or combinations thereof. Moreexamples of suitable polymer materials are described below.

In another embodiment shown in FIG. 2, the present disclosure provides amulti-chambered container 110 including a body 112 made of at least twoplies of a flexible polymer film defining a first chamber 130, a secondchamber 140, a third chamber 150, and a fourth chamber 160 formedbetween the plies. The container 110 may be made from, for example, twoor more plies of the film that are sealed about the periphery of thecontainer 110 at edges 114, 116, 118 and 120.

A first peelable seal 132 separates the first chamber 130 and the fourthchamber 160. The first peelable seal 132 is independently openable byselective application of external pressure to the first chamber 130. Asecond peelable seal 142 separates the second chamber 140 and the fourthchamber 160, The second peelable seal 142 is independently openable byselective application of external pressure to the second chamber 140. Athird peelable seal 152 separates the third chamber 150 and the fourthchamber 160. The third peelable seal 152 is independently openable byselective application of external pressure to the third chamber 150.

The first chamber 130 is separated from the second chamber 140 by apermanent seal 162 defining a transverse opening 164 through the plies.The second chamber 140 is separated from the third chamber 150 by apermanent seal 166 defining a transverse opening 168 through the plies.The first chamber 130, second chamber 140, and the third chamber 150 canbe dimensioned to facilitate one-handed gripping of the chamber to applythe external pressure.

In an embodiment, the transverse openings 164 and 168 have a width (sideto side) greater than 5 mm. The transverse openings 164 and 168 can alsohave a larger width such as, for example, a width greater than 6 mm,greater than 7 mm, greater than 8 mm, greater than 9 mm, greater than 10mm, and the like. In another embodiment, the openings 164 and 168 have alength (top to bottom) greater than 5 cm. The transverse openings 164and 168 can also have a larger length such as, for example, a widthgreater than 6 cm, greater than 7 cm, greater than 8 cm, greater than 9cm, greater than 10 cm, greater than 11 cm, greater than 12 cm, greaterthan 13 cm, greater than 14 cm, greater than 15 cm, greater than 16 cm,greater than 17 cm, greater than 18 cm, greater than 19 cm, greater than20 cm, and the like. For example, the transverse openings 164 and 168can be dimensioned to admit a human hand 70 to apply the externalpressure.

In an embodiment, the fourth chamber 160 is sized to facilitate mixingof the contents of any combination of the first, second, and thirdchambers 130, 140, and 150. The container 110 can further include afluid outlet port 170 in fluid communication with the fourth chamber160. A peelable safety seal 172 can separate the outlet port 170 fromthe fourth chamber 160. The safety seal 172 can have a seal strengthselected to impede opening of the safety seal 172 unless at least one ofthe first, second, and third peelable seals 132, 142, and 152 have firstbeen opened.

The container 110 can also include one or more tubes 174 in fluidcommunication with at least one of the first chamber 130, the secondchamber 140, and the third chamber 150. Tubes 174 may function primarilyas fill ports for the chambers 130, 140, and 150 and could bepermanently sealed after filling, but may also be provided with aresealable closure to allow components to be added to or removed fromthe corresponding chambers. Similarly, the container 110 can alsoinclude one or more tubes 176 in fluid communication with chamber 160.Tube 176 can be equipped with a septum 178 or similar resealable closureso that medications or other additives may be added to chamber 160without compromising the integrity of the container.

It should be appreciated that multi-chambered containers having morethan 3 storage chambers and/or more than 1 mixing chamber can be made inaccordance with alternative embodiments of the present disclosure. Forexample, the multi-chambered containers can have 4, 5, 6, 7, 8, or morestorage chambers in combination with one or more mixing chambers.

In yet another embodiment, the present disclosure provides a method ofadministering a product such as, for example, a medical or apharmaceutical solution. The method comprises providing a containerincluding a first storage chamber having a first component, a secondstorage chamber having a second component, and a third mixing chamber,The container is constructed and arranged according to variousembodiments of the present disclosure.

The method further comprises compressing at least one of the firststorage chamber and the second storage chamber to allow a specifiedamount of a component from the corresponding compressed chamber to flowthrough into the mixing chamber. For example, continuous squeezing at acertain pressure can open the individual peelable seals allowing thedesired amount of the contents of the corresponding chamber to flow intothe mixing chamber. The squeezing can be performed by a user's handsqueezing the specific chamber.

The method can further comprise compressing the remaining chamber toallow a specified amount of component from the remaining compressedchamber to flow through into the mixing chamber to form a mixedcomponent. The components from the first and second chambers can bemixed in the third chamber and administered through a fluid outlet portin fluid communication with the third chamber to a patient. The peelableseals can be re-closed to prevent the mixed solution from returning tothe storage chambers and/or for storing any remaining component in thestorage chambers.

The containers in alternative embodiments of the present disclosure canbe fabricated using standard sealing techniques. For example, thecontainer can be typically formed by placing one or more polymeric filmplies forming the first sidewall and second sidewall of the containerbody in registration by their peripheral portions and sealing theirperiphery to form a liquid tight pouch having an outer permanent seal.The polymeric film plies can be sealed, for example, by heat sealing,radio frequency sealing, thermal transfer welding, adhesive sealing,solvent bonding, and ultrasonic or laser welding.

The peelable seals can be formed prior to, during, or after forming thepermanent seal and can be made using appropriate sealing techniques suchas, for example, heat conduction. The welding die for the peelable sealsmay have different temperatures and shapes along its length and/or edgesto achieve the desired peelable seal configurations.

Blown extrusion is another method that may be used to make the pouch.Blown extrusion is a process that provides a moving tube of extrudateexiting an extrusion die. Air under pressure inflates the tube.Longitudinal ends of the tube are sealed to form the pouch. Blownextrusion only requires seals along two peripheral surfaces, where thesingle or multiple sheet registration method requires seals along threeor four peripheral surfaces to form the pouch.

The Sidewall Materials and Layer Structures

The containers 10 and 110 can be made principally of flexible polymericmaterials, although the container could include non-polymeric materialssuch as metal foils without departing from the disclosure. Numerouspolymeric films have been developed for use in containers. Suitablefilms may be of a monolayer structure or a multiple layer structure. Themonolayer structure can be made from a single polymer, or from a polymerblend. The multiple layer structures can include layers such as asolution contact layer, a scratch resistant layer, a barrier layer forpreventing permeation of gas (such as carbon dioxide, oxygen or watervapor), tie layers, or other layers. It is also contemplated to use morethan one web of film for one or both sidewalls. Selection of theappropriate film depends on the solution or solutions to be containedwithin the container. Appropriate polymeric materials are generallyselected from homopolymers and copolymers of polyolefins, polyamides,polyesters, polybutadiene, styrene and hydrocarbon copolymers,polyimides, polyester-polyethers, polyamide-polyethers to name a few.

The seal layer for a multi-chambered container should display bi-modalbehavior. What is meant by bi-modal behavior is that the material iscapable of forming a permanent seal under one set of sealing ormanufacturing conditions and a peelable seal at a second set of sealingor manufacturing conditions. The seal layer can be a homophase polymer,or a matrix-phase polymer system. Suitable homophase polymers includepolyolefins and more preferably polypropylene and most preferably apropylene and ethylene copolymer as described in EP 0875231, which isincorporated herein by reference.

It is also possible to have a seal layer having container walls ofdiffering materials that are not compatible with one another. U.S.patent application Ser. No. 10/351,004, which is incorporated herein byreference, discloses that containers made from such incompatiblematerial, in some instances, may not readily form permanent seals. Thisproblem can be overcome by wrapping a section of one sidewall over anoutside surface of the opposite sidewall and joined thereto. This methodof sealing is disclosed in U.S. Pat. No. 6,024,220 which is incorporatedherein by reference and made a part hereof.

Suitable matrix-phase polymer systems will have at least two components.The two components can be blended together or can be produced in atwo-stage reactor process. Typically, the two components will havedifferent melting point or glass transition temperatures. In the casewhere one of the components is amorphous, its glass transitiontemperature will be lower than the melting point of the othercomponents. Examples of suitable matrix-phase polymer system includes acomponent of a homopolymer or copolymer of a polyolefin and a secondcomponent of a styrene and hydrocarbon copolymer. Another suitablematrix-phase system includes blends of polyolefins such as polypropylenewith polyethylene, or polypropylene with a high isotactic index(crystalline) with polypropylene with a lower isotactic index(amorphous), or a polypropylene homopolymer with a propylene andα-olefin copolymer.

Suitable polyolefins include homopolymers and copolymers obtained bypolymerizing alpha-olefins containing from 2 to 20 carbon atoms, andmore preferably from 2 to 10 carbons. Therefore, suitable polyolefinsinclude polymers and copolymers of propylene, ethylene, butene-1,pentene-1,4-methyl-1-pentene, hexene-1, heptene-1, octene-1, nonene-1and decene-1. Most preferably the polyolefin is a homopolymer orcopolymer of propylene or a homopolymer or copolymer of polyethylene.

Suitable homopolymers of polypropylene can have a stereochemistry ofamorphous, isotactic, syndiotactic, atactic, hemiisotactic orstereoblock. In one preferred form of the disclosure, the homopolymer ofpolypropylene is obtained using a single site catalyst.

Suitable copolymers of propylene are obtained by polymerizing apropylene monomer with an α-olefin having from 2 to 20 carbons. In amore preferred form of the disclosure, the propylene is copolymerizedwith ethylene in an amount by weight from about 1% to about 20%, morepreferably from about 1% to about 10% and most preferably from 2% toabout 5% by weight of the copolymer. The propylene and ethylenecopolymers may be random or block copolymers. The propylene copolymermay also be obtained using a single site catalyst.

It is also possible to use a blend of polypropylene and α-olefincopolymers wherein the propylene copolymers can vary by the number ofcarbons in the α-olefin. For example, the present disclosurecontemplates blends of propylene and α-olefin copolymers wherein onecopolymer has a 2 carbon α-olefin and another copolymer has a 4 carbonα-olefin. It is also possible to use any combination of α-olefins from 2to 20 carbons and most preferably from 2 to 8 carbons. Accordingly, thepresent disclosure contemplates blends of propylene and α-olefincopolymers wherein a first and second α-olefins have the followingcombination of carbon numbers: 2 and 6, 2 and 8, 4 and 6, 4 and 8. It isalso contemplated using more than 2 polypropylene and α-olefincopolymers in the blend. Suitable polymers can be obtained using acatalloy procedure. Suitable homopolymers of ethylene include thosehaving a density of greater than 0.915 g/cc and includes low densitypolyethylene (LDPE), medium density polyethylene (MDPE) and high densitypolyethylene (HDPE).

Suitable copolymers of ethylene are obtained by polymerizing ethylenemonomers with an α-olefin having from 3 to 20 carbons, more preferably3-10 carbons and most preferably from 4 to 8 carbons. It is alsodesirable for the copolymers of ethylene to have a density as measuredby ASTM D-792 of less than about 0.915 g/cc and more preferably lessthan about 0.910 g/cc and even more preferably less than about 0.900g/cc. Such polymers are oftentimes referred to as VLDPE (very lowdensity polyethylene) or ULDPE (ultra low density polyethylene).Preferably the ethylene α-olefin copolymers are produced using a singlesite catalyst and even more preferably a metallocene catalyst systems.Single site catalysts are believed to have a single, sterically andelectronically equivalent catalyst position as opposed to theZiegler-Natta type catalysts which are known to have a mixture ofcatalysts sites. Such single-site catalyzed ethylene α-olefins are soldby Dow under the trade name AFFINITY, DuPont Dow under the trademarkENGAGE®, Eastman Kodak under the trade name MXSTEN, and by Exxon underthe trade name EXACT. These copolymers shall sometimes be referred toherein as m-ULDPE.

Suitable copolymers of ethylene also include ethylene and lower alkylacrylate copolymers, ethylene and lower alkyl substituted alkyl acrylatecopolymers and ethylene vinyl acetate copolymers having a vinyl acetatecontent of from about 8% to about 40% by weight of the copolymer. Theterm “lower alkyl acrylates” refers to comonomers having the formula setforth in Diagram 1:

The R group refers to alkyls having from 1 to 17 carbons. Thus, the term“lower alkyl acrylates” includes but is not limited to methyl acrylate,ethyl acrylate, butyl acrylate and the like.

The term “alkyl substituted alkyl acrylates” refers to comonomers havingthe formula set forth in Diagram 2:

R₁ and R₂ are alkyls having 1-17 carbons and can have the same number ofcarbons or have a different number of carbons. Thus, the term “alkylsubstituted alkyl acrylates” includes but is not limited to methylmethacrylate, ethyl methacrylate, methyl ethacrylate, ethyl ethacrylate,butyl methacrylate, butyl ethacrylate and the like.

Suitable polybutadienes include the 1,2- and 1,4-addition products of1,3-butadiene (these shall collectively be referred to aspolybutadienes). In a more preferred form of the disclosure, the polymeris a 1,2-addition product of 1,3 butadiene (these shall be referred toas 1,2 polybutadienes). In an even more preferred form of thedisclosure, the polymer of interest is a syndiotactic 1,2-polybutadieneand even more preferably a low crystallinity, syndiotactic 1,2polybutadiene. In a preferred form of the disclosure, the lowcrystallinity, syndiotactic 1,2 polybutadiene will have a crystallinityless than 50%, more preferably less than about 45%, even more preferablyless than about 40%, even more preferably the crystallinity will be fromabout 13% to about 40%, and most preferably from about 15% to about 30%.In a preferred form of the disclosure, the low crystallinity,syndiotactic 1,2 polybutadiene will have a melting point temperaturemeasured in accordance with ASTM D 3418 from about 70° C. to about 120°C. Suitable resins include those sold by JSR (Japan Synthetic Rubber)under the grade designations: JSR RB 810, JSR RB 820, and JSR RB 830.

Suitable polyesters include polycondensation products of di-orpolycarboxylic acids and di or poly hydroxy alcohols or alkylene oxides.In a preferred form of the disclosure, the polyester is a polyesterether. Suitable polyester ethers are obtained from reacting 1,4cyclohexane dimethanol, 1,4 cyclohexane dicarboxylic acid andpolytetramethylene glycol ether and shall be referred to generally asPCCE. Suitable PCCE's are sold by Eastman under the trade name ECDEL.Suitable polyesters further include polyester elastomers which are blockcopolymers of a hard crystalline segment of polybutylene terephthalateand a second segment of a soft (amorphous) polyether glycols. Suchpolyester elastomers are sold by DuPont Chemical Company under the tradename HYTREL®.

Suitable polyamides include those that result from a ring-openingreaction of lactams having from 4-12 carbons. This group of polyamidestherefore includes nylon 6, nylon 10 and nylon 12. Acceptable polyamidesalso include aliphatic polyamides resulting from the condensationreaction of di-amines having a carbon number within a range of 2-13,aliphatic polyamides resulting from a condensation reaction of di-acidshaving a carbon number within a range of 2-13, polyamides resulting fromthe condensation reaction of dimer fatty acids, and amide containingcopolymers. Thus, suitable aliphatic polyamides include, for example,nylon 6,6, nylon 6,10 and dimer fatty acid polyamides.

Suitable styrene and hydrocarbon copolymers include styrene and thevarious substituted styrenes including alkyl substituted styrene andhalogen substituted styrene. The alkyl group can contain from 1 to about6 carbon atoms. Specific examples of substituted styrenes includealpha-methylstyrene, beta-methylstyrene, vinyltoluene, 3-methylstyrene,4-methylstyrene, 4-isopropylstyrene, 2,4-dimethylstyrene,o-chlorostyrene, p-chlorostyrene, o-bromostyrene,2-chloro-4-methylstyrene, etc. Styrene is the most preferred.

The hydrocarbon portion of the styrene and hydrocarbon copolymerincludes conjugated dienes. Conjugated dienes which may be utilized arethose containing from 4 to about 10 carbon atoms and more generally,from 4 to 6 carbon atoms. Examples include 1,3-butadiene,2-methyl-1,3-butadiene (isoprene), 2,3-dimethyl-1,3-butadiene,chloroprene, 1,3-pentadiene, 1,3-hexadiene, etc. Mixtures of theseconjugated dienes also may be used such as mixtures of butadiene andisoprene. The preferred conjugated dienes are isoprene and1,3-butadiene.

The styrene and hydrocarbon copolymers can be block copolymers includingdi-block, tri-block, multi-block, star block and mixtures of the same.Specific examples of di-block copolymers include styrene-butadiene,styrene-isoprene, and the hydrogenated derivatives thereof. Examples oftri-block polymers include styrene-butadiene-styrene,styrene-isoprene-styrene,alpha-methylstyrene-butadiene-alpha-methylstyrene, andalpha-methylstyrene-isoprene-alpha-methylstyrene and hydrogenatedderivatives thereof.

The selective hydrogenation of the above block copolymers may be carriedout by a variety of well known processes including hydrogenation in thepresence of such catalysts as Raney nickel, noble metals such asplatinum, palladium, etc., and soluble transition metal catalysts.Suitable hydrogenation processes which can be used are those wherein thediene-containing polymer or copolymer is dissolved in an inerthydrocarbon diluent such as cyclohexane and hydrogenated by reactionwith hydrogen in the presence of a soluble hydrogenation catalyst. Suchprocedures are described in U.S. Pat. Nos. 3,113,986 and 4,226,952, thedisclosures of which are incorporated herein by reference and made apart hereof.

Particularly useful hydrogenated block copolymers are the hydrogenatedblock copolymers of styrene-isoprene-styrene, such as astyrene-(ethylene/propylene)-styrene block polymer. When apolystyrene-polybutadiene-polystyrene block copolymer is hydrogenated,the resulting product resembles a regular copolymer block of ethyleneand 1-butene (EB). As noted above, when the conjugated diene employed isisoprene, the resulting hydrogenated product resembles a regularcopolymer block of ethylene and propylene (EP). One example of acommercially available selectively hydrogenated copolymer is KRATON®G-1652 which is a hydrogenated SBS tri-block having 30% styrene endblocks and a mid-block equivalent is a copolymer of ethylene and1-butene (EB). This hydrogenated block copolymer is often referred to asSEBS. Other suitable SEBS or SIS copolymers are sold by Kuraray underthe tradename SEPTON® and HYBRAR®. It may also be desirable to use graftmodified styrene and hydrocarbon block copolymers by grafting analpha,beta-unsaturated monocarboxylic or dicarboxylic acid reagent ontothe selectively hydrogenated block copolymers described above.

The block copolymers of the conjugated diene and the vinyl aromaticcompound are grafted with an alpha, beta-unsaturated monocarboxylic ordicarboxylic acid reagent. The carboxylic acid reagents includecarboxylic acids per se and their functional derivatives such asanhydrides, imides, metal salts, esters, etc., which are capable ofbeing grafted onto the selectively hydrogenated block copolymer. Thegrafted polymer will usually contain from about 0.1 to about 20%, andpreferably from about 0.1 to about 10% by weight based on the totalweight of the block copolymer and the carboxylic acid reagent of thegrafted carboxylic acid. Specific examples of useful monobasiccarboxylic acids include acrylic acid, methacrylic acid, cinnamic acid,crotonic acid, acrylic anhydride, sodium acrylate, calcium acrylate andmagnesium acrylate, etc. Examples of dicarboxylic acids and usefulderivatives thereof include maleic acid, maleic anhydride, fumaric acid,mesaconic acid, itaconic acid, citraconic acid, itaconic anhydride,citraconic anhydride, monomethyl maleate, monosodium maleate, etc. Thestyrene and hydrocarbon block copolymer can be modified with an oil suchas the oil modified SEBS sold by the Shell Chemical Company under theproduct designation KRATON G2705.

The films used in the containers of the present disclosure can be amultiple layer film having a seal layer, an intermediate layer, and anexternal layer. Tie layers may be employed to attach the seal layer tothe intermediate layer and to attach the intermediate layer to theexternal layer. In a preferred form of the disclosure the seal layer isa blend of polypropylene, an ethylene α-olefin copolymer and a styreneand hydrocarbon copolymer. In a more preferred form of the disclosure,the polypropylene is a polypropylene ethylene copolymer, the ethyleneα-olefin copolymer is a LLDPE having a density of less than 0.915 g/ccand the styrene and hydrocarbon copolymer is a block copolymer andpreferably a tri-block copolymer of styrene-ethylene-butylene-styrene ora blend of an SEBS tri-block with an SEBS di-block as a minor component.The relative proportions of the components are preferably from about 55%to 75% of the PP by weight, from 5% to 20% by weight of the LLDPE, andfrom 10% to 20%o by weight of the SEBS. The ternary blend of the seallayer is capable of forming a permanent seal and a peelable seal at atemperature of from about 123 to 128° C. A permanent seal is achieved atsealing temperatures above 145° C.

The intermediate layer may be selected from any of the polyamides setforth herein and most preferably is a blend of from about 85 to 98%polyamide 6 and from 2 to 15% polyamide 6I,6T. The external layer can beselected from polypropylene polymer. For example, the external layer canbe a propylene ethylene copolymer with an ethylene content of less than6% by weight of the copolymer.

The details of the films are more fully set out in U.S. patentapplication Ser. No. 09/439,826, filed Nov. 12, 1999, which isincorporated in its entirety herein by reference and made a part hereof.

Another suitable film can contain three layers: an external layer,intermediate layer, and seal layer. The external layer can be a reactormade polypropylene composition having a first component and a secondcomponent. The first component can be a polypropylene homopolymer andcan be present in an amount by weight of the composition of 40%. Thesecond component can be an ethylene-propylene rubber (ethylene 20% andpropylene 80%) and can be present in an amount by weight of thecomposition of 60%. Suitable products for the external layer are sold byMitsubishi Chemical Company under the trade name Zelas 7023. Zelas 7023is the subject of U.S. Patent Application Publication No. 2001/0034416A1 which is incorporated herein by reference in its entirety and made apart hereof.

The intermediate layer can be a polymer blend of Zelas 7023 70% byweight and 30% by weight of a random copolymer of styrene and butadienethat has been hydrogenated. Suitable random copolymers of styrene andbutadiene are sold by JSR under the trade name Dynaron 2320 P.

The external layer can be a polymer blend of 60% by weight Zelas 7023and 40% by weight of a random copolymer of propylene and ethylene suchas the copolymer sold under the trade name Novatec EG 7C. The films candisplay bi-modal behavior with peelable seals being formed at sealingtemperatures of about 125° C. and permanent seals are obtained at about145° C.

Other suitable films for this application include those disclosed inU.S. Pat. Nos. 5,849,843; 5,998,019; 6,083,587; 6,297,046; 5,139,831;5,577,369; and U.S. Application No. 2003/0077466 A1, which areincorporated herein in their entirety by reference and made a parthereof.

EXAMPLES

The multi-chambered containers can contain the following components inthe storage and mixing chambers in alternative embodiments:

-   -   The mixing/holding chamber contains a base peritoneal dialysis        solution. A glucose concentrate is in one of the storage        chambers. Another glucose concentrate is in a second storage        chamber. An amino acid concentrate is in a third storage        chamber. A polyglucose concentrate is in a fourth storage        chamber.

This would allow a patient or care giver to selectively mix one or moreconcentrates into a ready-to-use improved solution (over the basesolution initially contained in the holding/mixing chamber). Thedifferent glucose concentrates can provide an iso-osmolar solution or alow osmolarity solution or a high osmolar solution by adding none, one,or two glucose concentrate solution(s) into the holding/mixing chamber.

-   -   The mixing/holding chamber contains a base peritoneal dialysis        solution. One of the storage chambers contains a bicarbonate        concentrate. A second storage chamber contains a glucose or        polyglucose concentrate. Mixing the contents of the two storage        chambers into the holding/mixing chamber would provide the        patient/care giver with a ready-to-use bicarbonate buffered,        polyglucose-based solution for a long dwell.    -   The mixing/holding chamber contains a base peritoneal dialysis        solution. One of the storage chambers contains a bicarbonate        concentrate. A second storage chamber contains an amino acid        concentrate. Mixing the contents of the two storage chambers        into the holding/mixing chamber would provide the patient/care        giver with a ready-to-use bicarbonate buffered nutritional amino        acid based solution for infusion in conjunction with a meal.    -   The mixing/holding chamber is initially empty. One of the        storage chambers contains a glucose based solution. A second        storage chamber contains and amino acid based solution. A third        storage chamber contains a lipid based emulsion. A fourth        chamber contains a trace element based solution. Mixing the        contents of two or more storage chambers would give respectively        nutritional solutions similar to the two-in-one or three-in-one        solutions contained in conventional two chambered or three        chambered bags that could be supplemented with trace elements if        necessary. The trace elements can be contained in one of the        storage chambers as described above.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

1. A container comprising: a first chamber, a second chamber, and a third chamber; a first peelable seal separating the first and third chambers, the first peelable seal being independently openable by selective application of external pressure to the first chamber; and a second peelable seal separating the second and third chambers, the second peelable seal being independently openable by selective application of external pressure to the second chamber, wherein the first chamber is separated from the second chamber by a permanent seal defining a transverse opening.
 2. The container of claim 1, wherein at least one of the first chamber and second chamber is dimensioned to facilitate one-handed gripping of the chamber to apply the external pressure.
 3. The container of claim 1, wherein the transverse opening is dimensioned to admit a human hand to apply the external pressure.
 4. The container of claim 1, wherein the third chamber contains a parenterally administrable base solution.
 5. The container of claim 1, wherein the third chamber is empty and is sized to contain the entire contents of the first chamber and the second chamber.
 6. The container of claim 1, wherein the container is made from a film comprising at least one material selected from the group consisting of polyolefins, polyamides, polyesters, polybutadiene, styrene and hydrocarbon copolymers, polyimides, polyester-polyethers, polyamide-polyethers, and combinations thereof.
 7. The container of claim 1, wherein the film comprises at least one material selected from the group consisting of polyethylene homopolymers, ethylene α-olefin copolymers, polyethylene copolymers, polypropylene homopolymers, polypropylene copolymers, styrene and hydrocarbon random copolymers, styrene and hydrocarbon block copolymers, and combinations thereof.
 8. The container of claim 1, wherein the first peelable seal and the second peelable seal are activated by a force ranging from about 3 N/15 mm to about 30 N/15 mm.
 9. The container of claim 1, wherein the first peelable seal has a first activating force and the second peelable seal has a second activating force, the second peelable seal activating force is greater than the first peelable seal activating force.
 10. The container of claim 9, wherein the difference between the first peelable seal activating force and the second peelable seal activating force is greater than about 1 N/15 mm and less than about 5 N/15 mm.
 11. The container of claim 1, wherein at least a portion of the first peelable seal and the second peelable seal comprises a shape selected from the group consisting of semicircular, rectangular, trapezoidal, polygonal, and combinations thereof.
 12. The container of claim 1, wherein the first chamber and the second chamber contain components of a peritoneal dialysis solution.
 13. The container of claim 1, wherein the first chamber and the second chamber contain components of a parenteral nutrition solution.
 14. The container of claim 1 further comprising a fluid outlet port in fluid communication with the third chamber.
 15. The container of claim 14 further comprising a peelable safety seal separating the outlet port from the third chamber, wherein the safety seal has a seal strength selected to impede opening of the safety seal unless at least one of the first and second peelable seals have first been opened.
 16. The container of claim 1 further comprising a tube in fluid communication with at least one of the first chamber and the second chamber.
 17. A multi-chambered container comprising: at least two plies of a flexible polymer film defining a first chamber, a second chamber, and a third chamber formed between the plies; a first peelable seal separating the first and third chambers, the first peelable seal being independently openable by selective application of external pressure to the first chamber; and a second peelable seal separating the second and third chambers, the second peelable seal being independently openable by selective application of external pressure to the third chamber, wherein the first and third chambers are separated by a permanent seal defining a transverse opening through the plies.
 18. The multi-chambered container of claim 17, wherein at least one of the first chamber and second chamber is dimensioned to facilitate one-handed gripping of the chamber to apply the external pressure.
 19. The multi-chambered container of claim 17, wherein the transverse opening is dimensioned to admit a human hand to apply the external pressure.
 20. A multi-chambered container comprising: at least two plies of a flexible polymer film defining a first chamber, a second chamber, a third chamber, and a fourth chamber formed between the plies; a first peelable seal separating the first and fourth chambers, the first peelable seal being independently openable by selective application of external pressure to the first chamber; a second peelable seal separating the second and fourth chambers, the second peelable seal being independently openable by selective application of external pressure to the second chamber; and a third peelable seal separating the third and fourth chambers, the third peelable seal being independently openable by selective application of external pressure to the third chamber, wherein the first chamber is separated from the second chamber by a first permanent seal defining a transverse opening through the plies and the second chamber is separated from the third chamber by a second permanent seal defining a transverse opening through the plies.
 21. The multi-chambered container of claim 20, wherein at least one of the first chamber, second chambers and the third chamber is dimensioned to facilitate one-handed gripping of the chamber to apply the external pressure.
 22. The multi-chambered container of claim 20, wherein the transverse opening is dimensioned to admit a human hand to apply the external pressure.
 23. The multi-chambered container of claim 20, wherein the fourth chamber is sized to facilitate mixing of the contents of any combination of the first, second, and third chambers.
 24. The multi-chambered container of claim 20 further comprising a fluid outlet port in fluid communication with the fourth chamber.
 25. The multi-chambered container of claim 24 further comprising a peelable safety seal separating the outlet port from the fourth chamber, wherein the safety seal has a seal strength selected to impede opening of the safety seal unless at least one of the first, second, and third peelable seals have first been opened.
 26. The multi-chambered container of claim 20 further comprising a tube in fluid communication with at least one of the first chamber, the second chamber, and the third chamber.
 27. A method of administering a product, the method comprising: providing a container comprising: a first chamber comprising a first component, a second chamber comprising a second component, and a third chamber, a first peelable seal separating the first and third chambers, the first peelable seal being independently openable by selective application of external pressure to the first chamber, and a second peelable seal separating the second and third chambers, the second peelable seal being independently openable by selective application of external pressure to the second chamber, wherein the first chamber is separated from the second chamber by a permanent seal defining a transverse opening; and compressing at least one of the first chamber and the second chamber to allow the component from the compressed chamber to flow through into the third chamber.
 28. The method of claim 27, wherein the squeezing is performed by a user's hand squeezing the chamber.
 29. The method of claim 27 further comprising compressing a remaining chamber to allow the component from the compressed chamber to flow through into the third chamber to form a mixed component.
 30. The method of claim 29 further comprising administering the mixed component through a fluid outlet port in fluid communication with the third chamber. 